...
Researchers must follow procedures to meet compliance as outlined in the eConsent REDCap Template for CFR Part 11 Validated Project project template. Fields and forms may be ammended based on study requirements. For FDA regulated studies, this template should be used as is.
...
| Expand | ||
|---|---|---|
| ||
Copy the consent instrument, and rename it with the version number appended and suffix _v2 added to variables.   In the survey settings, make sure to edit the e-consent Framework fields to the new v2 variables. In the Optional fields, you can enter the type (i.e. Adult, Assent, Parental Permission Form). Make sure to save your changes.  Make sure to inactivate old Automated Survey Invitations (ASIs), modify Alerts, or modify the Survey Queue depending on your distribution method.     It may be beneficial to add form display logic for your new consent instruments. In this example, if v1 is being used up to 12/10/2022, I will update the logic for both instruments to follow that.  Inactivate the old version of the consent survey by turning the status to “Survey Offline” in the survey settings.  Submit your changes for review. Once the changes have been approved, don’t forget to add user rights to your new instrument(s). For further instructions see the Add, Edit, Remove Users From Your Own Project knowledge article. |
...